DDI HV (ATV - Merck)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00518297
First received: August 17, 2007
Last updated: February 3, 2010
Last verified: November 2008

August 17, 2007
February 3, 2010
August 2007
December 2007   (final data collection date for primary outcome measure)
  • Safety Assessments [ Time Frame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge ]
  • Pharmacokinetic Assessments [ Time Frame: Days 5, 12, and 26 ]
  • Safety Assessment: Electrocardiograms [ Time Frame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge ]
  • Pharmacokinetic Assessments: Cmin [ Time Frame: Days 5, 12, and 26 ]
  • Safety Assessment: Vital Signs [ Time Frame: Screening, Days 1, 5, 12, 19, 26, and study discharge ]
  • Safety Assessment:Physical Examinations [ Time Frame: Screening, Days 1, 5, 12, 19, 26, and study discharge) ]
  • Safety Assessment: Physical measurements [ Time Frame: Screening, Days 1, 26, and Study Discharge ]
  • Safety Assessment: Adverse Events [ Time Frame: All days from screening to study discharge ]
  • Safety Assessment: Laboratory Test Assessments [ Time Frame: Screening, Days -1, 5, 12, 26, and Study Discharge ]
  • Pharmacokinetic Assessment: Cmax [ Time Frame: Days 5, 12, and 26 ]
  • Pharmacokinetic Assessment: AUC [ Time Frame: Days 5, 12, and 26 ]
Complete list of historical versions of study NCT00518297 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DDI HV (ATV - Merck)
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects

The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Raltegravir
    Tablet, Oral, 400 mg, twice daily for 5 Days
  • Drug: Atazanavir
    Capsule, Oral, 300 mg, twice daily for 7 Days
    Other Name: Reyataz
  • Drug: Atazanavir + Raltegravir
    Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
    Other Name: Reyataz
  • Active Comparator: 1
    Intervention: Drug: Raltegravir
  • Active Comparator: 2
    Intervention: Drug: Atazanavir
  • Active Comparator: 3
    Intervention: Drug: Atazanavir + Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
  • Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
  • Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
  • Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00518297
AI424-352
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP